Primary Endpoint Met in CoFactor Metastatic Colorectal Cancer Trial

Adventrx Pharmaceuticals has announced that the primary endpoint for response rate was met in the study, "COFU: A multicenter Phase II clinical trial to evaluate the safety and efficacy of weekly treatment with CoFactor and 5-fluorouracil in patients with metastatic colorectal carcinoma."

Further clinical data will be collected as the remaining patients continue to undergo evaluation. CoFactor is a biomodulator developed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU).

This open-label, single arm, Simon two-stage design Phase II CoFactor clinical trial includes patients with surgically incurable, metastatic colon or rectal adenocarcinoma. Response rate is defined in this Phase II trial as the tumor shrinking at least 50 percent, based on World Health Organization criteria, or complete response following treatment as measured by computed tomography or magnetic resonance imaging scans. Other endpoints being evaluated are safety, time-to-tumor-progression and overall survival.